DETAILED ACTION
A restriction requirement was mailed 20 February 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 7 April 2026 (“Reply”).
Status of the Claims
The listing of claims filed 8 January 2024 via Preliminary Amendment has been examined. Claims 1–15 are pending. Claims 3–7, 9, and 15 are amended.
Election/Restrictions
Applicant’s election without traverse of claims 1–9 (Group I) in the Reply is acknowledged. Claims 10–15 (Group II), directed to a non-elected invention, are withdrawn.
Priority
The instant application was filed 8 January 2024; is a national stage application of PCT/CN2022/115484, filed 28 August 2022, and claims priority to CN 202111043276.4, filed 7 September 2021. Applicant’s claim for foreign priority is acknowledged, and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8 January 2024; 9 December 2024; and 21 November 2025 are acknowledged and have been considered.
Objections to the Specification
The abstract is objected to because it recites legal phraseology (“comprising”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1–9 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim 1 (step a) recites a list of solvents followed by “preferably selected from . . .”
Claim 1 (step c) recites a number of washings followed by “preferably 10 to 15 . . .”
Claim 3 recites a temperature range followed by “preferably 50°C . . .”
Claim 4 recites a volume ratio followed by “preferably 10:1 . . .”
Claim 5 recites a pumping velocity followed by “preferably 70 ml/min . . . such as . . .”
Claim 6 recites a temperature range followed by “preferably 0°C . . .”
Claim 7 recites a velocity range followed by “preferably 500 rpm . . .”
Claim 8 recites a velocity range followed by “preferably 1.57m/s . . .”
Claim 9 recites a particle binder followed by “such as sodium chloride.”
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Dependent claim 2 incorporates all limitations from claim 1 without resolving the issues.
Appropriate correction is required.
Allowable Subject Matter
Claims 1–9 are rejected above, but would be allowable if rewritten to overcome the formal issues. The closest prior art reference is AU 2013253518 (English language translation of CN107536802, cited in IDS; “Otsuka”). Otsuka discloses a general method of preparing an injection of brexpiprazole comprising dissolving a vehicle in water and suspending the compound therein. (Otsuka , p.30). Otsuka discloses a specific method of preparing an injection of brexpiprazole comprising dissolving a vehicle (PEG, sodium chloride, DL-methionine, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, and polysorbate) in water, filtering the resulting solution, and adding the compound to the solution to make a suspension. (Id., pp.45–46). These methods do not disclose or suggest dissolving brexpiprazole in a solvent, adding that solution to an anti-solvent to precipitate brexipiprazole, filtering, and drying or dispersing the solid, as claimed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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